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Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients (ICOGEN)

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ClinicalTrials.gov Identifier: NCT01040780
Recruitment Status : Completed
First Posted : December 30, 2009
Results First Posted : May 24, 2012
Last Update Posted : February 14, 2014
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Interventions Drug: Icotinib
Drug: Gefitinib
Enrollment 399
Recruitment Details Patients were enrolled between 26 Febrary 2009 and 13 November 2010 across 27 study sites.
Pre-assignment Details  
Arm/Group Title Icotinib Gefitinib
Hide Arm/Group Description Icotinib 125 mg three times daily (375 mg per day) by mouth Gefitinib 250 mg every 24 hours by mouth
Period Title: Overall Study
Started 200 199
Completed 199 196
Not Completed 1 3
Reason Not Completed
Protocol Violation             1             3
Arm/Group Title Icotinib Gefitinib Total
Hide Arm/Group Description Icotinib 125 mg three times daily (375 mg per day) by mouth Gefitinib 250 mg every 24 hours by mouth Total of all reporting groups
Overall Number of Baseline Participants 200 199 399
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 199 participants 399 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
164
  82.0%
159
  79.9%
323
  81.0%
>=65 years
36
  18.0%
40
  20.1%
76
  19.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants 199 participants 399 participants
55.52  (10.14) 56.43  (9.43) 55.98  (9.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 199 participants 399 participants
Female
82
  41.0%
85
  42.7%
167
  41.9%
Male
118
  59.0%
114
  57.3%
232
  58.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 200 participants 199 participants 399 participants
200 199 399
1.Primary Outcome
Title Progression Free Survival
Hide Description Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
Time Frame 2-7 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of study drug with measurable disease at baseline.
Arm/Group Title Icotinib Gefitinib
Hide Arm/Group Description:
125 mg three times daily (375 mg per day) by mouth
250 mg every 24 hours by mouth
Overall Number of Participants Analyzed 199 196
Median (95% Confidence Interval)
Unit of Measure: months
4.6
(3.5 to 6.3)
3.4
(2.3 to 3.8)
2.Secondary Outcome
Title Overall Survival
Hide Description Median number of months from first study treatment until time of death
Time Frame From first study treatment until time of death
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icotinib Gefitinib
Hide Arm/Group Description:
125 mg three times daily (375 mg per day) by mouth
250 mg daily by mouth
Overall Number of Participants Analyzed 199 196
Median (95% Confidence Interval)
Unit of Measure: months
13.3
(11.1 to 16.2)
13.9
(11.4 to 17.3)
3.Secondary Outcome
Title Best Tumor Response
Hide Description Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline
Time Frame While receiving study treatment; assessed every 21 days until progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icotinib Gefitinib
Hide Arm/Group Description:
Icotinib 125 mg three times daily (375 mg per day) by mouth
Gefitinib 250 mg every 24 hours by mouth
Overall Number of Participants Analyzed 199 196
Measure Type: Number
Unit of Measure: percentage of patients
Complete Response (CR) 0.5 0
Partial Response (PR) 27.1 27.2
Stable Disease (SD) 47.7 47.7
Progressive Disease (PD) 21.1 20.5
Disease Control (CR+PR+SD) 75.4 74.9
4.Secondary Outcome
Title Time To Progression
Hide Description Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression.
Time Frame 2-7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icotinib Gefitinib
Hide Arm/Group Description:
Icotinib 125 mg three times daily (375 mg per day) by mouth
Gefitinib 250 mg every 24 hours by mouth
Overall Number of Participants Analyzed 199 196
Median (95% Confidence Interval)
Unit of Measure: months
5.2
(3.6 to 6.6)
3.7
(2.5 to 5.0)
5.Secondary Outcome
Title Safety and Tolerability
Hide Description

Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Icotinib or Gefitinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.

Grade 3 = Severe Grade 4 = Life-threatening or disabling
Time Frame Assessed over two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icotinib Gefitinib
Hide Arm/Group Description:
Icotinib 125 mg three times daily (375 mg per day) by mouth
Gefitinib 250 mg every 24 hours by mouth
Overall Number of Participants Analyzed 200 199
Measure Type: Number
Unit of Measure: participants
At least one AE 166 165
At least one ADR 121 140
At least one SAE 13 15
Grade 3 and 4 AEs 9 10
Time Frame [Not Specified]
Adverse Event Reporting Description Events were collected by systematic assessment
 
Arm/Group Title Icotinib Gefitinib
Hide Arm/Group Description Icotinib 125 mg three times daily (375 mg per day) by mouth Gefitinib 250 mg every 24 hours by mouth
All-Cause Mortality
Icotinib Gefitinib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Icotinib Gefitinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/200 (6.50%)      15/199 (7.54%)    
Cardiac disorders     
Cardiac failure † 1  2/200 (1.00%)  2 0/199 (0.00%)  0
Cardio-respiratory failure † 1  1/200 (0.50%)  1 0/199 (0.00%)  0
Gastrointestinal disorders     
Vomiting † 1  0/200 (0.00%)  0 1/199 (0.50%)  1
Intestinal obstruction † 1  1/200 (0.50%)  1 0/199 (0.00%)  0
Anorexia † 1  0/200 (0.00%)  0 1/199 (0.50%)  1
General disorders     
Haemorrhage † 1  1/200 (0.50%)  1 0/199 (0.00%)  0
Multi-organ failure † 1  1/200 (0.50%)  1 2/199 (1.01%)  2
Hospitalization due to progression † 1  1/200 (0.50%)  1 0/199 (0.00%)  0
Infections and infestations     
Pneumonia † 1  0/200 (0.00%)  0 2/199 (1.01%)  2
Injury, poisoning and procedural complications     
Injury * 1  0/200 (0.00%)  0 1/199 (0.50%)  1
Nervous system disorders     
Dizziness † 1  1/200 (0.50%)  1 0/199 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory failure † 1  4/200 (2.00%)  4 5/199 (2.51%)  5
Haemoptysis † 1  1/200 (0.50%)  1 2/199 (1.01%)  2
Pleural effusion † 1  1/200 (0.50%)  1 1/199 (0.50%)  1
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Icotinib Gefitinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   166/200 (83.00%)      165/199 (82.91%)    
Blood and lymphatic system disorders     
Leukopenia † 1  9/200 (4.50%)  9 12/199 (6.03%)  12
Gastrointestinal disorders     
Diarrhea † 1  43/200 (21.50%)  43 58/199 (29.15%)  58
Anorexia † 1  11/200 (5.50%)  11 14/199 (7.04%)  14
Nausea † 1  8/200 (4.00%)  8 13/199 (6.53%)  13
Vomiting † 1  9/200 (4.50%)  9 12/199 (6.03%)  12
Mucositis of oral cavity † 1  10/200 (5.00%)  10 9/199 (4.52%)  9
General disorders     
Pain † 1  36/200 (18.00%)  36 22/199 (11.06%)  22
Pyrexia † 1  6/200 (3.00%)  6 17/199 (8.54%)  17
Hepatobiliary disorders     
Hepatic Function Abnormal † 1  10/200 (5.00%)  10 11/199 (5.53%)  11
Investigations     
Aminotransferase Increased † 1  21/200 (10.50%)  21 26/199 (13.07%)  26
Respiratory, thoracic and mediastinal disorders     
Cough † 1  17/200 (8.50%)  17 22/199 (11.06%)  22
Hemoptysis † 1  12/200 (6.00%)  12 16/199 (8.04%)  16
Skin and subcutaneous tissue disorders     
Rash † 1  81/200 (40.50%)  81 98/199 (49.25%)  98
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yan Sun, M.D.
Organization: Cancer Hospital, Chinese Academy of Medical Sciences
Phone: 0086-010-87788519
EMail: zhangheping@csco.org.cn
Publications of Results:
Shi Y, Zhang L, Liu X, Zhou C, Zhang L, Zhang S, Wang D, Li Q, Qin S, Hu C, Zhang Y, Chen J, Cheng Y, Feng J, Zhang H, Song Y, Wu YL, Xu N, Zhou J, Luo R, Bai C, Jin Y, Liu W, Wei Z, Tan F, Wang Y, Ding L, Dai H, Jiao S, Wang J, Liang L, Zhang W, Sun Y. Icotinib versus gefitinib in previously treated advanced non-small-cell lung cancer (ICOGEN): a randomised, double-blind phase 3 non-inferiority trial. Lancet Oncol. 2013 Sep;14(10):953-61. doi: 10.1016/S1470-2045(13)70355-3. Epub 2013 Aug 13.
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01040780    
Other Study ID Numbers: BPI-2009
First Submitted: December 27, 2009
First Posted: December 30, 2009
Results First Submitted: February 21, 2012
Results First Posted: May 24, 2012
Last Update Posted: February 14, 2014